(30 days)
Not Found
No
The description focuses on Bioelectrical Impedance Analysis (BIA) technology and data transmission, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is used to measure body composition parameters and aims to provide information about overall health and fitness, not to treat or diagnose a disease or condition.
No.
The device measures various body composition parameters and is intended for health and fitness monitoring, not for diagnosing diseases or medical conditions.
No
The device description clearly outlines hardware components like a scale, BIA technology electrodes, an LCD display, and a wireless network connections module. While it transmits data to other devices, the core measurement and analysis are performed by the physical device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Transtek Glass Body Fat Analyzer measures physical characteristics of the body (weight, body fat, water percentage, bone mass, muscle mass) using bioelectrical impedance analysis. It does not analyze samples taken from the body.
- Intended Use: The intended use is for estimating body composition in generally healthy adults for home use, not for diagnosing or monitoring diseases or conditions based on analysis of biological samples.
The device is a body composition analyzer, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The TRANSTEK Glass Body Fat Analyzer measure weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, muscle mass, and bone mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only.
Product codes
MNW
Device Description
Transtek Glass Body Fat Analyzer uses BIA (Bioelectrical Impedance Analysis) technology which passes an electrical current through the body to estimate body fat mass, total body water, muscle mass and bone mass. The electrical current is low and may not be felt. The current passes freely through the fluids contained in muscle tissue, but encounters difficulty/resistance when it passes through fat tissue. This resistance of the fat tissue to the current is termed 'Bioelectrical Impedance', and is accurately measured by Glass Body Fat Analyzer LS206-E. This method simultaneously calculates your personal weight, body fat, total body water, muscle mass and bone mass, giving you a more accurate reading of your overall health and fitness. This scale stores the personal data of up to 4 users. As well as being an analyzer, this device can be used as a conventional weight scale. Transtek Glass Body Fat Analyzer LS206-E embeds a Wireless network connections module that allows it to connect to nearby receiving end (such as specific equipment that named Bridge) which is connected to the Internet. Once measurement is over, the LCD of device displays results. And the device will start to send out data. The Bridge receive / storage, and transmission data to Internet server. Thus users can receive, and display/storage, measurement results from LS206-E unit through their end devices (e.g. PC, cellular, tablet) that connected Internet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
home/domestic setting only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Design control activities for this modification were performed and bench tests have been done. Those performance tests, risk management, and design verification tests provide demonstration that the difference does not raise any new questions of safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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Section 5 - 510(k) Summary
Date of Summary Preparation: 11/30/2012
1. Submitter's Identifications
Submitter's Name: ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. Address: Jin'an Road, Minzhong, Zhongshan City, Guangdong, China Contact Person: Lisa Li Contact Email Address: lishal@transtek.cn Telephone: 086-760-88282982 ext. 876 Fax: 086-760-85339231
2. Correspondent's Identifications
Correspondent's Name: A03 Lab of BTS Address: No.1 Fanghua Street, Hi-tech Zone, Chengdu City, Sichuan, China Contact Person: Leo Wang Contact Email Address: leo.w@hibts.com Telephone: 086-28-86083300 Fax: 086-20-80727399
3. Name of the Device
Device Classification Name: Analyzer, Body Composition (Impedance Plethysmograph) Product Name: Glass Body Fat Analyzer Trade/Proprietary Name: TRANSTEK Glass Body Fat Analyzer Model: LS206-E Classification Panel: Cardiovascular Common/Usual Name: Body Composition Analyzer/Scales Product Code: MNW Device Classification: Class II Contraindications: Do not use the Analyzer if you have a pacemaker or other internal medical device.
'4. The Predicate Devices
TRANSTEK, Glass Body Fat Analyzer, Model GBF-950-D. K112932
5. Device Description
Transtek Glass Body Fat Analyzer uses BIA (Bioelectrical Impedance Analysis) technology which passes an electrical current through the body to estimate body fat mass, total body water, muscle mass and bone mass. The electrical current is low and may not be felt. The current passes freely through the
Section 5 - 510(k) Summary
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AN 0 9 2013
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fluids contained in muscle tissue, but encounters difficulty/resistance when it passes through fat tissue. This resistance of the fat tissue to the current is termed 'Bioelectrical Impedance', and is accurately measured by Glass Body Fat Analyzer LS206-E.
This method simultaneously calculates your personal weight, body fat, total body water, muscle mass and bone mass, giving you a more accurate reading of your overall health and fitness.
This scale stores the personal data of up to 4 users. As well as being an analyzer, this device can be used as a conventional weight scale.
Transtek Glass Body Fat Analyzer LS206-E embeds a Wireless network connections module that allows it to connect to nearby receiving end (such as specific equipment that named Bridge) which is connected to the Internet. Once measurement is over, the LCD of device displays results. And the device will start to send out data. The Bridge receive / storage, and transmission data to Internet server. Thus users can receive, and display/storage, measurement results from LS206-E unit through their end devices (e.g. PC, cellular, tablet) that connected Internet.
6. Intended Use of Device
The TRANSTEK Glass Body Fat Analyzer measure weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, muscle mass, and bone mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only.
7. Design Control Activities and Performance Tests Summary
Design control activities for this modification were performed and bench tests have been done. Those performance tests, risk management, and design verification tests provide demonstration that the difference does not raise any new questions of safety and effectiveness.
LS206-E conforms to the following standards:
ISO14971, Risk management to medical devices
IEC60601-1, Electrical safety; IEC60601-1-2, Electromagnetic compatibility
FCC Part 15, EMI tests of FCC Radiation & RF rules and regulations
Explanation: The new wireless function does not affect body analyzer measurement function. Therefore we have not done the Clinical test.
8. Summary of Substantial Equivalence
8.1 Differences between proposed device and the predicate device
The only significant function difference between the two devices is that LS206-E add-on a wireless data communication, what user option, which can transmit measurement results to those end devices which connected Internet.
More modification details are described in this submission.
Section 5 - 510(k) Summary
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8.2 Discussion
The Transtek Glass Body Fat Analyzer LS206-E has identical indication for use, fundamental scientific technology, energy type, dimensional specifications, and similar performance specifications, software/firmware, functions, labeling to the predicate device.
The only function difference between LS206-E and the predicate device is that the modified device provides user an optional wireless data transmission. It is an add-on function that is entirely independent from the body analyzer function, which does not reply on the wireless connection to carry out a bioelectrical impedance analysis and display its results. Thus the wireless data transmission function does not affect the safety and effectiveness of the body analyzer function.
9. Conclusions
The Transtek Glass Body Fat Analyzer LS206-E is substantially equivalent to the predicate device GBF-950-D by having the identical indication for use, identical technologies, and an add-on function which does not impact the safety and effectiveness of the device.
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Image /page/3/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human figures or shapes, arranged in a way that suggests movement or progress.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9, 2013
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. % Mr. Leo Wang Senior Consultant A03 Lab of BTS No. 1 Fanghua Street, Hi-tech District CHENGDU SICHUAN CHINA 610041
Re: K123781
Trade/Device Name: Transtek Glass Body Fat Analyzer Models: LS206-E Regulation Number: 21 CFR§ 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: December 10, 2012 Received: December 10, 2012
Dear Mr. Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert R. Lerner
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4 - Indications for Use
510(k) Number (if known):
KI23781/
Device Name:
Transtek Glass Body Fat Analyzer Models: LS206-E
Indications for Use:
The Transtek Glass Body Fat Analyzer measure weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older.
It is intended for use in the home/domestic setting only.
Prescription Use
AND/OR
× Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert R. Lerner
ductive, Gastro-Rena
Section 4 - Indications for Use
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